CompletedNot Applicable

Electrical Stimulation Effect on Ankle Instability During Walking in Virtual Reality Setup

United States32 participantsStarted 2024-05-29

Plain-language summary

The purpose of the study is to investigate whether electrical stimulation to leg muscles and joints can help with balance in people with ankle instability. Participants will be asked to walk on a treadmill in a virtual reality cave. They will receive light electrical stimulation at the legs to improve your balance. The virtual reality image will sometimes shift in unexpected ways to challenge your balance. During the session, we will conduct a series of clinical assessments, including tests of functional performance and balance. Additionally, participants will be asked to fill out some questionnaires.

Who can participate

Age range

18 Years – 39 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 - 39 years. * Having at least one significant ankle sprain in the past year, which causes a minimum of one interrupted day of physical activity. * Having a history of at least two ankle sprains or "giving way" sensations at the injured ankle and/or a history of general feeling of ankle joint instability associated with the fear of getting another acute ankle sprain. * Score \< 24 in the Cumberland Ankle Instability Tool (CAIT), and/or \> 11 in the Identification of Functional Ankle Instability (IdFAI), and/or answer ''yes'' to at least 5 yes/no questions in the Ankle Instability Instrument (AII). Exclusion Criteria: * Any head, neck, or face injury in the six months prior to the study (e.g., concussion, eye injury). * History of vestibular or ocular dysfunction. * Currently taking any medications affecting balance (i.e. antibiotics). * History of injuries to lower extremities including fractures, knee injuries, and hip injuries. * Sustaining an ankle sprain injury in the last 6 weeks. * Pregnancy * Any neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, history of stroke) * Unstable cardiac or pulmonary disease. * Clinically obese (BMI 30 or above). * Any metal implant in the feet or legs that is close to the stimulating electrodes. * A known allergy to medical-grade adhesives. * Any other comorbidity affecting the ability to safely walk without assistance for a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the Center of Mass (CoM) excursion

Timeframe: At the end of the session after 12 walking trials of randomized stimulation.

Trial details

NCT IDNCT06484712

SponsorUniversity of Delaware

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-09

View on ClinicalTrials.gov More Ankle Sprains trials